A Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00118638
First received: June 30, 2005
Last updated: April 25, 2013
Last verified: April 2013

June 30, 2005
April 25, 2013
March 2004
December 2004   (final data collection date for primary outcome measure)
Incidence of at least one RBC transfusion from week 5 to End of Treatment Period (EOTP) [ Time Frame: from week 5 to EOTP ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00118638 on ClinicalTrials.gov Archive Site
  • Incidence of achieving a hemoglobin concentration of greater than or equal to 11.0 g/dL, in the absence of RBC transfusions in the preceding 28 days, from week 5 to EOTP [ Time Frame: from week 5 to EOTP ] [ Designated as safety issue: No ]
  • Incidence of at least one RBC transfusion from week 1 (day 1) to EOTP [ Time Frame: from week 1 (day 1) to EOTP ] [ Designated as safety issue: No ]
  • Incidence of achieving a hemoglobin concentration greater than or equal to 11.0 g/dL, in the absence of RBC transfusions in the preceding 28 days, from week 1 to EOTP [ Time Frame: from week 1 to EOTP ] [ Designated as safety issue: No ]
  • Change in FACT-G Physical Well-being subscale from baseline to EOTP [ Time Frame: from baseline to EOTP ] [ Designated as safety issue: No ]
  • Change in hemoglobin from baseline to EOTP [ Time Frame: from baseline to EOTP ] [ Designated as safety issue: No ]
  • Change in FACT-Fatigue subscale score from baseline to EOTP [ Time Frame: from baseline to EOTP ] [ Designated as safety issue: No ]
  • Change in FACT-G total score from baseline to EOTP [ Time Frame: from baseline to EOTP ] [ Designated as safety issue: No ]
  • Change in EQ-5D Thermometer from baseline to EOTP [ Time Frame: from baseline to EOTP ] [ Designated as safety issue: No ]
  • Change in BSI Anxiety scale score from baseline to EOTP [ Time Frame: from baseline to EOTP ] [ Designated as safety issue: No ]
  • Change in BSI Depression scale score from baseline to EOTP [ Time Frame: from baseline to EOTP ] [ Designated as safety issue: No ]
  • Incidence and severity of adverse events [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
  • Incidence of hemoglobin concentration greater than 13.0 g/dL at any time on study [ Time Frame: at any time on study ] [ Designated as safety issue: Yes ]
  • Change in number of caregiver hours from baseline to EOTP [ Time Frame: from baseline to EOTP ] [ Designated as safety issue: No ]
  • Incidence of an increase in hemoglobin concentration greater than or equal to 2 g/dL in a 28-day window and any negative clinical consequences [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
  • Incidence of an increase in hemoglobin concentration of greater than or equal to 1 g/dL in a 14-day window and any negative clinical consequences [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
  • Incidence of a confirmed antibody formation to darbepoetin alfa [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
A Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy
A Randomized, Double Blind, Active-Controlled Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy

The purpose of this study is to evaluate the efficacy of darbepoetin alfa as 500ug once every 3 weeks to show that the dose and schedule are not inferior to darbepoetin alfa administered as 2.25ug/kg once per week in the treatment of anemia in subjects with non-myeloid malignancies.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Anemia
  • Non-Myeloid Malignancies
  • Drug: Darbepoetin alfa - 2.25 mcg/kg
    Darbepoetin alfa 2.25 mcg/kg QW dosing/ placebo Q3W
  • Drug: Darbepoetin alfa - 500mcg
    Darbepoetin alfa 500mcg Q3W dosing / placebo QW
  • Experimental: Darbepoetin alfa 500 mcg - Group A
    Intervention: Drug: Darbepoetin alfa - 500mcg
  • Active Comparator: Darbepoetin alfa 2.25 mcg/kg - Group B
    Intervention: Drug: Darbepoetin alfa - 2.25 mcg/kg

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
705
January 2005
December 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Non-myeloid malignancy
  • At least 12 additional weeks of cyclic cytotoxic chemotherapy anticipated regardless of schedule
  • Eastern Cooperative Oncology Group performance status of 0-2
  • Hemoglobin concentration of less than 11 g/dL within 24 hours before randomization
  • Of legal age at the time written informed consent is obtained

Exclusion Criteria:

  • Known history of seizure disorder
  • Known primary hematologic disorder, which could cause anemia, other than a non-myeloid malignancy
  • Unstable or uncontrolled disease/condition, related to or affecting cardiac function
  • Clinically significant inflammatory disease
  • Inadequate renal and/or liver function
  • Known positive HIV test
  • Previously suspected of or confirmed to have neutralizing antibodies to rHuEPO
  • Received more than 2 red blood cell (RBC) transfusions within 4 weeks before randomization or any RBC transfusion within 14 days before randomization, or any planned RBC transfusion between randomization and study day 1
  • Received any erythropoietic therapy within 4 weeks before randomization or any planned erythropoietic therapy between randomization and study day 1
  • Other investigational procedures
  • Subject is currently enrolled in or less than 30 days since receipt of any investigational drug or device that is not approved by the applicable regulatory authority
  • Pregnant or breast feeding
  • Not using adequate contraceptive precautions
  • Known sensitivity to any of the products to be administered during dosing
  • Previously randomized in this study
  • Concerns for subject's compliance with protocol procedures
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00118638
20030231
Not Provided
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP